New Data Support Role for Monitoring of Cell-Mediated Immunity in Adult Patients Following Renal Transplantation

 Cylex's ImmuKnow(R) assay shows clinical potential in independent study of

                      adult kidney transplant patients



    COLUMBIA, Md., Aug. 21 /EMWNews/ -- A recently published article by

Sanchez-Velasco et al.* in Clinical Transplantation has expanded our

understanding of the clinical potential of monitoring cell-mediated

immunity in adult patients at risk for organ rejection or infection

subsequent to kidney transplantation.



    Pablo Sanchez-Velasco and his colleagues in the Cantabria Health System

and at the University of Cantabria, in Santander, Spain, used the Cylex

ImmuKnow assay to prospectively monitor intracellular adenosine

triphosphate (ATP) concentrations following CD4 cell activation as a

measure of cell- mediated immune function in 81 immunosuppressed adults who

underwent kidney transplantation. The objective of their study was to

examine the association between cell-mediated immunity and risk for organ

rejection (in under- immunosuppressed patients) or systemic infection (in

over-immunosuppressed patients). Their data were also compared to

intracellular ATP levels in 52 (non-transplanted) healthy controls.



    Their results demonstrated a clear correlation between intracellular

ATP levels for the healthy control group, a group of stable transplant

patients, and infected transplant patients, with a statistically

significant difference between the median ATP levels for these three

groups:






    -- Infected transplant group (n = 24): mean ATP level = 197 +/- 114 ng/mL

    -- Stable transplant group (n = 54):   mean ATP level = 313 +/- 193 ng/mL

    -- Healthy control group (n = 52):     mean ATP level = 409 +/- 177 ng/mL



    These ATP levels correlate relatively closely to the three categories

of cell-mediated immunity defined for adult transplant patients in the

product's package insert.



    Only three patients in this trial underwent an acute rejection episode

during the course of this study. The authors state that this was an

insufficient number of patients to validate the role of the ImmuKnow assay

in monitoring risk for organ rejection. The mean ATP level of the three

patients who underwent acute organ rejection was 247 +/- 193 ng/mL.



    "We are pleased to see the data from this study support earlier

published data on the use of the ImmuKnow assay in monitoring adult

patients after a renal transplant," stated Brad L. Stewart, president of

Cylex. "Clearly there is further research needed to elucidate the

appropriate standards for use of cell-mediated immunity to monitor risk for

infection and rejection in selected patient categories. However, this

publication further illustrates the potential risks for infection

associated with over-immunosuppression in renal transplant patients, and

the potential value of the ImmuKnow assay in monitoring immune status."



    *Sanchez-Velasco P, Rodrigo E, Valero R, et al. Intracellular ATP

concentrations of CD4 cells in kidney transplant patients with and without

infection. Clin Transplant. 2008;22:55-60.

    About ImmuKnow(R)



    ImmuKnow is the immune cell function assay cleared by the FDA to detect

cell-mediated immunity (CMI) in adult patient populations undergoing

immunosuppressive therapy for organ transplantation by measuring the

concentration of adenosine triphosphate (ATP) released from CD4 cells

following cell stimulation.



    The ImmuKnow test is a qualitative assay and does not directly quantify

the level of immunosuppression. Results of ImmuKnow assays should be used

in conjunction with clinical presentation, medical history, and other

clinical indicators when assessing the immune status of any individual

patient. The uses of the ImmuKnow assay as described in these studies have

not been approved or cleared by the FDA. The Company may use data from

these or similar studies to support future FDA marketing applications for

similar indications.



    About Cylex, Inc.



    Cylex(TM) is a privately held global life sciences company that is the

leader in the development and manufacture of in vitro diagnostic products

intended to illuminate immunity. The Company's patented technology provides

an innovative platform allowing clinical researchers to simply and

reproducibly measure immune cell function for the development of new

diagnostics, biomarkers, and companion assays. The Company is based in

Columbia, MD, USA.